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FDA 510(k)

Treace Medical Concepts (TMC) Plating System

K-Number: K153531 · 2016-01-07

ApplicantTreace Medical Concepts, Inc.
Decision Date2016-01-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Treace Medical Concepts (TMC) Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2016-01-07 under 510(k) number K153531. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Treace Medical Concepts (TMC) Plating System?

Treace Medical Concepts (TMC) Plating System is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K153531.

When did Treace Medical Concepts (TMC) Plating System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Plating System received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153531.

Who is the listed applicant for Treace Medical Concepts (TMC) Plating System?

The FDA 510(k) record lists Treace Medical Concepts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Treace Medical Concepts (TMC) Plating System?

The FDA product code for Treace Medical Concepts (TMC) Plating System is HRS.

Other records listing Treace Medical Concepts, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260361Treace Medical Concepts (TMC) Screw Fixation SystemK251135Treace Medical Concepts (TMC) Implant Fixation SystemK243658TMC Compression Implant SystemK242671Treace Medical Concepts (TMC) Screw Fixation SystemK242415TMC Compression Implant SystemK240173Treace Medical Systems (TMC) Plating System

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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